Non-small Cell Lung Cancer Stage IIPhase 2DYNAPETNCT04586465
Dynamic PET/CT Evaluated the Response of Neoadjuvant Anti-PD1 Combination With Chemotherapy for Ⅱa-Ⅲb NSCLC
A Phase 2 study testing pembrolizumab, pemetrexed, gemcitabine, cisplatin, carboplatin in people with Non-small Cell Lung Cancer Stage II and Non-small Cell Lung Cancer Stage III, run by Fifth Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
The neoadjuvant Immune Checkpoint Inhibitor (ICI) or ICI combination with chemotherapy for Non-small cell lung cancer (NSCLC) had induced higher major pathologic response (MPR) and complete pathological response (PCR). However, the RECIST underestimated the therapeutic response of neoadjuvant ICI therapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-small Cell Lung Cancer Stage II, Non-small Cell Lung Cancer Stage III, PET/CT
- What is being tested?
- pembrolizumab, pemetrexed, gemcitabine, cisplatin, carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteChina
- Study dates
- 10 Oct 2020to 30 Jun 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed NSCLC, performed on a biopsy that occurred within the last 60 days
- Computed tomography (CT) and Dynamic PET-CT within the last 30 days showing radiographic stage Ⅱa to Ⅲb lung cancer (mediastinal staging biopsy is allowed but not required) by the American Joint Committee on Cancer (AJCC) 8th edition
- Potentially surgically resectable by a senior thoracic surgeon
- No driver gene mutation.
- Age≥18 years, and ≤75 years
- Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by the investigator
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- Adequate tissue specimens for correlative biomarker analysis. The patient should be willing to provide tissue from a newly obtained biopsy of a tumor lesion and surgical resected tumor lesion.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Resolution of all acute toxic effects of prior chemotherapy, radiotherapy or surgical procedures to NCI CTCAE version (v)5.0 grade 1
- Be willing and able to provide written informed consent for the trial
- Absolute neutrophil count (ANC) >= 1500 cells/ microlitre(uL) (within 10 days prior to the start of trial treatment). Platelets >= 100 000 cells/uL (within 10 days prior to the start of trial treatment). Hemoglobin >= 9.0 g/dL or >= 5.6 mmol/L (criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks) (within 10 days prior to the start of trial treatment). Creatinine =< 1.5 x upper limit of normal (ULN) OR measured or calculated creatinine clearance, glomerular filtration rate (GFR) can also be used in place of creatinine or creatinine clearance (CrCl) >= 30 mL/min for patients with creatinine levels > 1.5 x institutional ULN (within 10 days prior to the start of trial treatment)
- Total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for patients with total bilirubin levels > 1.5 x ULN (within 10 days prior to the start of trial treatment)
- Aspartate aminotransferase (AST) or serum glutamic-oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT) or serum glutamate pyruvate transaminase（SGPT) =< 2.5 x ULN (=< 5 x ULN for patients with liver metastases) (within 10 days prior to the start of trial treatment)
- International normalized ratio (INR) OR prothrombin time (PT) =< 1.5 x ULN unless patient is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants (within 10 days prior to the start of trial treatment)
- Activated partial thromboplastin time (aPTT)/PTT =< 1.5 x ULN unless patient is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants (within 10 days prior to the start of trial treatment)
- Female patients of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of trial medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
- Male and female patients of childbearing potential must be willing to use an adequate method of contraception as outlined, for the course of the trial through 120 days after the last dose of trial drug o Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the patient
Who cannot join
- Any approved anticancer therapy, including chemotherapy, hormonal therapy, or radiotherapy, within 5 years prior to initiation of study treatment; however, the following are allowed:
- Hormone-replacement therapy or oral contraceptives
- Herbal therapy > 1 week prior to Cycle 1, Day 1 (herbal therapy intended as anticancer therapy must be discontinued at least 1 week prior to Cycle 1, Day 1)
- Malignancies other than the disease under study within 5 years prior to Cycle 1, Day 1, with the exception of those with a negligible risk of metastasis or death and with expected curative outcome or undergoing active surveillance per standard-of-care management (e.g., chronic lymphocytic leukemia Rai Stage 0, prostate cancer with Gleason score ≤ 6, and prostate-specific antigen (PSA) ≤ 10 mg/mL, etc.)
- Patients who are receiving any other investigational agents concurrently.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to pembrolizumab, cisplatin, carboplatin, pemetrexed or gemcitabin.
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- Patients with active hepatitis B or C infections or a history of HIV infection.
- Patients with past or resolved hepatitis B infection, defined as having a negative hepatitis B surface antigen (HBsAg) test and a positive for the antibody test to detect antibodies to hepatitis B core antigen (anti-HBc) are eligible.
- Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection including tuberculosis (TB), symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis; cirrhosis; fatty liver; and inherited liver disease
- Patients with controlled Type 1 diabetes mellitus on a stable insulin regimen may be eligible.
- Severe infections within 4 weeks prior to Cycle 1, Day 1, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
- Signs or symptoms of infection within 2 weeks prior to Cycle 1, Day 1 Received oral or IV antibiotics within 2 weeks prior to Cycle 1, Day 1. Patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or chronic obstructive pulmonary disease) are eligible
- Major surgical procedure within 28 days prior to Cycle 1, Day 1 or anticipation of need for a major surgical procedure during the course of the study
- Administration of a live, attenuated vaccine within 4 weeks before Cycle 1, Day 1 or anticipation that such a live, attenuated vaccine will be required during the study
- Pregnant women
- History of interstitial lung disease or pneumonitis of any cause
- Is ineligible for an operation based on medical or oncologic contraindications to surgery
- Is currently participating in or has participated in a trial of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of trial treatment o Note: Patients who have entered the follow-up phase of an investigational trial may participate as long as it has been 4 weeks after the last dose of the previous investigational agent
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the fifth affiliated hospital of Sun yat-sen university
Zhuhai, Guangdong, 519000
Hua Cheng, PHD, 13926927891, chenghuagz@hotmail.com
About this study
Official title: Dynamic Positron Emission Tomography/Computed Tomography Evaluated the Response of Neoadjuvant Anti-programmed Cell Death Protein 1 Combination With Chemotherapy for Stage Ⅱa-Ⅲb Non-small Cell Lung Cancer
The neoadjuvant Immune Checkpoint Inhibitor (ICI) or ICI combination with chemotherapy for Non-small cell lung cancer (NSCLC) had induced higher major pathologic response (MPR) and complete pathological response (PCR). However, the RECIST underestimated the therapeutic response of neoadjuvant ICI therapy. In this study, dynamic PET/CT compared with RECEST 1.1 for the prediction of therapeutic response of NSCLC treated with neoadjuvant ICI combination with chemotherapy.
Read the detailed description
The prognosis of stage Ⅱa-Ⅲb NSCLC was worse, with 5-year survival rate between 26%-60% after resection. Neoadjuvant ICI or ICI combination with chemotherapy had induced high rate major pathologic response (MPR) and complete pathological response (PCR) for NSCLC. CT image (RECIST) underestimate the response of neoadjuvant therapy. In Checkmate 159 trial, 21 patients with stage Ⅰ-Ⅲa NSCLC received two dose preoperative Nivolumab, only 2 (10%) patients were partial response on CT image assessment. While 9 of 20 (45%) patients were MPR on pathological examination. 2 patients shows tumor progression on CT, but one patient achieved PCR and another patient achieved MPR.Therefore, conventional RECIST criteria cannot accurately assess tumor response to treatment.
The occurrence, development and metastasis of tumor are essentially a series of biochemical processes of abnormal gene expression and metabolism, dysfunction and structural change. 18F-FDG can reflect the metabolic changes of the body at the cellular and molecular level, and the transmission of these metabolic information is earlier than the anatomical changes. By detecting the uptake of 18F-FDG and analyzing tumor metabolism, tissue blood perfusion, receptor, etc., it can provide a theoretical basis for monitoring the therapeutic effect of lung cancer with PET.
As a new imaging technique, 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (18F-FDG) PET/CT is playing an increasingly important role in the diagnosis of tumors. 18F-FDG PET/CT reflects the glucose metabolism process of tumor tissues, and the diagnosis of benign and malignant tumors is based on the difference in glucose metabolism activity between tumor cells and normal tissue cells. 18F-FDG is an isomer of glucose, which is involved in glucose metabolism. Because it is deoxidized and cannot produce hexose bisphosphate, it cannot participate in the next metabolism, and is trapped in cells. In tumor cells, 18F-FDG uptake is increased due to high expression of glucose transport messenger ribonucleic acid (mRNA), elevated glucose transporter Glut-1 and Glut-3 levels, increased hexokinase expression, and down-regulation of glucose-6-phosphatase levels.Molecular imaging using 18F-FDG PET/CT can provide metabolic information to enable better differentiation of benign and malignant tissues and reveal functional abnormalities before structural damage. At the same time, 18F-FDG PET-CT is an effective method for early monitoring of tumor response. It can monitor the metabolic changes of the body before and after tumor treatment, so as to suggest the response of the body to relevant treatment. However, all the PET/CT scans reported in the relevant literature are based on routine static scans, that is, the image data is based on the static images of the tracer obtained at a fixed time point after injection of 18F-FDG. Conventional static PET (60min post-injection scan) can only be used for qualitative visual analysis or semi-quantitative indicator standardized uptake values (SUV) to determine tumor response to treatment. SUV is vulnerable to the influences of uptake time, blood glucose concentration, insulin level, individual weight and injection dose, making it difficult to accurately and quantitatively evaluate tumor response before and after treatment. In order to improve, we plan to adopt dynamic scanning, that is, collecting dynamic data of whole body tissues at all times from the instant of injection of 18F-FDG to one hour. Dynamic scanning can provide information about the temporal metabolism and distribution of the tracer in the tissue, so it can provide more abundant information about the metabolism and distribution of tumor foci and metastasis foci than static scanning, so it can accurately quantify the tumor response before and after treatment. At the same time dynamic PET does not increase the patient's radiation dose compared to static PET.
This study intends to evaluate the efficacy of neoadjuvant anti-programmed cell death protein 1 (anti-PD1) immunotherapy combined with chemotherapy followed by surgery, evaluate the evaluation value of dynamic PET-CT for the efficacy of neoadjuvant therapy, and evaluate the relationship between circulating tumor DNA (ctDNA) changes and efficacy.
- Being tested
- pembrolizumab, pemetrexed, gemcitabine, cisplatin, carboplatin
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pembrolizumab, pemetrexed, gemcitabine, cisplatin, carboplatinDrug
Also called Non
Patients will receive 3 cycles pembrolizumab 200mg, fix dose, 60 minute IV infusion combination with chemotherapy.
Chemotherapy regimen: ① Eligible patients with non-squamous cell lung cancer, Pemetrexed 500mg/m2, IV infusion on day 1 and cisplatin 75mg/m2 or carboplatin area under the curve (AUC=5), on day 1 of a 3-week schedule for 3 cycles. ② Eligible patients with squamous cell lung cancer. Patients will receive gemcitabine 1250mg/m2 IV on day 1 and day 8, and cisplatin 75mg/m2 or carboplatin AUC=5 on day 1 of a 3-week schedule for 3 cycles
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant ICI combination with chemotherapy for stage Ⅱ-Ⅲ NSCLC | Experimental | Eligible patients with clinical stage Ⅱ-Ⅲ NSCLC will receive dynamic PET-CT before and after 3 cycles neoadjuvant pembrolizumab plus chemotherapy, then patients receive surgical resection. Changes in tumor size were evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. Net uptake rate constant of FDG-Ki value based on dynamic PET will be calculated to evaluate Ki changes before and after treatment. Pathological tumor response were evaluated according to IASLC recommendations. Dynamic PET will be compared with RECIST whether it can better predict the pathological tumor response and disease free survival. Receives: Drug: pembrolizumab, pemetrexed, gemcitabine, cisplatin, carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major pathological response
10% or less residual viable tumor cells
Measured: up to 12 weeks; analysis of surgical resected tumor samples after neoadjuvant therapy
Dynamic SUV change
Dynamic PET-CT SUV change
Measured: up to 12 weeks; analysis change of SUV before and after neoadjuvant therapy
Objective response rate
CT image assessment of tumor response according to RECIST 1.1 criteria
Measured: up to 12 weeks; analysis change of before and after neoadjuvant therapy
uptake rate constant (Ki) changes
uptake rate constant (Ki) changes before and after neoadjuvant therapy
Measured: up to 12 weeks; before and after neoadjuvant therapy
Secondary outcomes (3)
Progression free survival
Time from enrollment to disease progression or death from any cause, whichever occurred first
Measured: up to 3 years
Treatment related adverse events
the number of adverse events related to ICI or platinum-based chemotherapy as evaluated according to CTCAE v4.0.
Measured: 12 weeks
ctDNA change
the amount of ctDNA before and after neoadjuvant therapy
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start10 Oct 2020
- Primary completion30 Nov 2021 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung Cancer Stage IIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Dynamic PET-CT compared with RECIST to predict therapeutic response treated with neoadjuvant ICI combined with chemotherapy for stage Ⅱ-Ⅲ NSCLC.
- Masking
- None (open label)
- Enrolment
- 23 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fifth Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04586465
- Sponsor's protocol ID
- ZDWY.XWK.003
- Acronym
- DYNAPET
- Status last verified
- Oct 2020
- First submitted
- 12 Oct 2020
- Last updated
- 24 Aug 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Positron Emission Tomography/Computed Tomography Evaluated the Response of Neoadjuvant Anti-programmed Cell Death Protein 1 Combination With Chemotherapy for Stage Ⅱa-Ⅲb Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT04586465
- Acronym / sponsor ID
- DYNAPET / ZDWY.XWK.003
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- Fifth Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 10 Oct 2020 (actual)
- Primary completion
- 30 Nov 2021 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 14 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The neoadjuvant Immune Checkpoint Inhibitor (ICI) or ICI combination with chemotherapy for Non-small cell lung cancer (NSCLC) had induced higher major pathologic response (MPR) and complete pathological response (PCR). However, the RECIST underestimated the therapeutic response of neoadjuvant ICI therapy. In this study, dynamic PET/CT compared with RECEST 1.1 for the prediction of therapeutic response of NSCLC treated with neoadjuvant ICI combination with chemotherapy.
Detailed description
The prognosis of stage Ⅱa-Ⅲb NSCLC was worse, with 5-year survival rate between 26%-60% after resection. Neoadjuvant ICI or ICI combination with chemotherapy had induced high rate major pathologic response (MPR) and complete pathological response (PCR) for NSCLC. CT image (RECIST) underestimate the response of neoadjuvant therapy. In Checkmate 159 trial, 21 patients with stage Ⅰ-Ⅲa NSCLC received two dose preoperative Nivolumab, only 2 (10%) patients were partial response on CT image assessment. While 9 of 20 (45%) patients were MPR on pathological examination. 2 patients shows tumor progression on CT, but one patient achieved PCR and another patient achieved MPR.Therefore, conventional RECIST criteria cannot accurately assess tumor response to treatment.
The occurrence, development and metastasis of tumor are essentially a series of biochemical processes of abnormal gene expression and metabolism, dysfunction and structural change. 18F-FDG can reflect the metabolic changes of the body at the cellular and molecular level, and the transmission of these metabolic information is earlier than the anatomical changes. By detecting the uptake of 18F-FDG and analyzing tumor metabolism, tissue blood perfusion, receptor, etc., it can provide a theoretical basis for monitoring the therapeutic effect of lung cancer with PET.
As a new imaging technique, 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (18F-FDG) PET/CT is playing an increasingly important role in the diagnosis of tumors. 18F-FDG PET/CT reflects the glucose metabolism process of tumor tissues, and the diagnosis of benign and malignant tumors is based on the difference in glucose metabolism activity between tumor cells and normal tissue cells. 18F-FDG is an isomer of glucose, which is involved in glucose metabolism. Because it is deoxidized and cannot produce hexose bisphosphate, it cannot participate in the next metabolism, and is trapped in cells. In tumor cells, 18F-FDG uptake is increased due to high expression of glucose transport messenger ribonucleic acid (mRNA), elevated glucose transporter Glut-1 and Glut-3 levels, increased hexokinase expression, and down-regulation of glucose-6-phosphatase levels.Molecular imaging using 18F-FDG PET/CT can provide metabolic information to enable better differentiation of benign and malignant tissues and reveal functional abnormalities before structural damage. At the same time, 18F-FDG PET-CT is an effective method for early monitoring of tumor response. It can monitor the metabolic changes of the body before and after tumor treatment, so as to suggest the response of the body to relevant treatment. However, all the PET/CT scans reported in the relevant literature are based on routine static scans, that is, the image data is based on the static images of the tracer obtained at a fixed time point after injection of 18F-FDG. Conventional static PET (60min post-injection scan) can only be used for qualitative visual analysis or semi-quantitative indicator standardized uptake values (SUV) to determine tumor response to treatment. SUV is vulnerable to the influences of uptake time, blood glucose concentration, insulin level, individual weight and injection dose, making it difficult to accurately and quantitatively evaluate tumor response before and after treatment. In order to improve, we plan to adopt dynamic scanning, that is, collecting dynamic data of whole body tissues at all times from the instant of injection of 18F-FDG to one hour. Dynamic scanning can provide information about the temporal metabolism and distribution of the tracer in the tissue, so it can provide more abundant information about the metabolism and distribution of tumor foci and metastasis foci than static scanning, so it can accurately quantify the tumor response before and after treatment. At the same time dynamic PET does not increase the patient's radiation dose compared to static PET.
This study intends to evaluate the efficacy of neoadjuvant anti-programmed cell death protein 1 (anti-PD1) immunotherapy combined with chemotherapy followed by surgery, evaluate the evaluation value of dynamic PET-CT for the efficacy of neoadjuvant therapy, and evaluate the relationship between circulating tumor DNA (ctDNA) changes and efficacy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Dynamic PET-CT compared with RECIST to predict therapeutic response treated with neoadjuvant ICI combined with chemotherapy for stage Ⅱ-Ⅲ NSCLC.
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant ICI combination with chemotherapy for stage Ⅱ-Ⅲ NSCLC | Experimental | Drug: pembrolizumab, pemetrexed, gemcitabine, cisplatin, carboplatinEligible patients with clinical stage Ⅱ-Ⅲ NSCLC will receive dynamic PET-CT before and after 3 cycles neoadjuvant pembrolizumab plus chemotherapy, then patients receive surgical resection. Changes in tumor size were evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. Net uptake rate constant of FDG-Ki value based on dynamic PET will be calculated to evaluate Ki changes before and after treatment. Pathological tumor response were evaluated according to IASLC recommendations. Dynamic PET will be compared with RECIST whether it can better predict the pathological tumor response and disease free survival. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Histologically or cytologically confirmed NSCLC, performed on a biopsy that occurred within the last 60 days
- Computed tomography (CT) and Dynamic PET-CT within the last 30 days showing radiographic stage Ⅱa to Ⅲb lung cancer (mediastinal staging biopsy is allowed but not required) by the American Joint Committee on Cancer (AJCC) 8th edition
- Potentially surgically resectable by a senior thoracic surgeon
- No driver gene mutation.
- Age≥18 years, and ≤75 years
Key exclusion criteria (20 listed)
- Any approved anticancer therapy, including chemotherapy, hormonal therapy, or radiotherapy, within 5 years prior to initiation of study treatment; however, the following are allowed:
- Malignancies other than the disease under study within 5 years prior to Cycle 1, Day 1, with the exception of those with a negligible risk of metastasis or death and with expected curative outcome or undergoing active surveillance per standard-of-care management (e.g., chronic lymphocytic leukemia Rai Stage 0, prostate cancer with Gleason score ≤ 6, and prostate-specific antigen (PSA) ≤ 10 mg/mL, etc.)
- Patients who are receiving any other investigational agents concurrently.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to pembrolizumab, cisplatin, carboplatin, pemetrexed or gemcitabin.
- Patients with active hepatitis B or C infections or a history of HIV infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pembrolizumab, pemetrexed, gemcitabine, cisplatin, carboplatinAlso: NonPatients will receive 3 cycles pembrolizumab 200mg, fix dose, 60 minute IV infusion combination with chemotherapy. Chemotherapy regimen: ① Eligible patients with non-squamous cell lung cancer, Pemetrexed 500mg/m2, IV infusion on day 1 and cisplatin 75mg/m2 or carboplatin area under the curve (AUC=5), on day 1 of a 3-week schedule for 3 cycles. ② Eligible patients with squamous cell lung cancer. Patients will receive gemcitabine 1250mg/m2 IV on day 1 and day 8, and cisplatin 75mg/m2 or carboplatin AUC=5 on day 1 of a 3-week schedule for 3 cycles | Drug | Neoadjuvant ICI combination with chemotherapy for stage Ⅱ-Ⅲ NSCLC |
Primary outcome
Major pathological response
Time frame: up to 12 weeks; analysis of surgical resected tumor samples after neoadjuvant therapy
10% or less residual viable tumor cells
Dynamic SUV change
Time frame: up to 12 weeks; analysis change of SUV before and after neoadjuvant therapy
Dynamic PET-CT SUV change
Objective response rate
Time frame: up to 12 weeks; analysis change of before and after neoadjuvant therapy
CT image assessment of tumor response according to RECIST 1.1 criteria
uptake rate constant (Ki) changes
Time frame: up to 12 weeks; before and after neoadjuvant therapy
uptake rate constant (Ki) changes before and after neoadjuvant therapy
3 secondary outcomes
Progression free survival
Time frame: up to 3 years
Treatment related adverse events
Time frame: 12 weeks
ctDNA change
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing pembrolizumab, pemetrexed, gemcitabine, cisplatin, carboplatin in people with Non-small Cell Lung Cancer Stage II and Non-small Cell Lung Cancer Stage III, run by Fifth Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact QingDong Cao, MD (0756-2528825, cqd8866@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major pathological response (time frame: up to 12 weeks; analysis of surgical resected tumor samples after neoadjuvant therapy). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2021; AzTrials last refreshed its copy on 6 Nov 2026.